responsibility finder
Schleswig-Holstein

Notify cosmetic products (possibly with nanomaterials) before placing them on the market

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6PLus)

Service Description

Cosmetic products are not subject to authorization. However, certain components of cosmetic products such as new preservatives, colorants and UV filters are exempt from this requirement. Regardless of which cosmetic product is involved, the safety of the product must be guaranteed. If you want to make a cosmetic product available on the European market for the first time, you as the "responsible person" (usually the manufacturer or importer, and possibly also the distributor) must provide some information about your product in advance. This is done via the notification portal for cosmetic products (Cosmetic Products Notification Portal, CPNP).

The CPNP is operated by the European Commission and enables uniform and centralized notification in all member states of the European Union.

The CPNP makes this information available electronically to

  • competent authorities (for the purposes of market surveillance, market analysis, evaluation and consumer information)
  • Poison information centers or similar bodies established by European Union countries (for the purpose of medical advice)

The CPNP is accessible to:

  • Persons responsible for cosmetic products
  • Distributors of cosmetic products
    • Notification in the CPNP does not include approval or verification of data. As a responsible person, you must ensure that the cosmetic products you place on the market are safe, that their intended use is guaranteed and that they comply with the legal provisions.
  • The CPNP is intended for manufacturers of nanomaterials in order to be able to add detailed information on nanomaterials used in a cosmetic product to the notification of the cosmetic product.

The CPNP includes 3 notification obligations that you as the responsible person must fulfill before your cosmetic product is placed on the market for the first time:

  • 1. information about the cosmetic product and its formulation, which will be made available to poison information centers for the purpose of providing prompt and appropriate advice in the event of adverse health effects.
  • 2. information on the cosmetic product without the formulation, which is made available to the competent authorities of the federal states for the purpose of monitoring.
  • 3. cosmetic products containing nanomaterials other than colorants, preservatives and UV filters must be notified 6 months before being placed on the market. This notification must be made in addition to the notification referred to in Article 13. This information is sent exclusively to the European Commission. If the European Commission has concerns about the safety of a nanomaterial, it may ask the Scientific Committee on Consumer Safety to carry out a risk assessment.
    • To fulfill this obligation, you as the responsible person can appoint a nanomaterial representative.

In cosmetic products, "nanomaterial" refers to a natural, process-derived or manufactured material consisting of solid particles that occur either independently or as recognizable constituent particles in aggregates or agglomerates, and where at least 50 percent of these particles in the number size distribution meet at least one of the following conditions:

(a) one or more external dimensions of the particles are in the size range of 1 nanometer (nm) to 100 nm;

b) the particles have an elongated shape such as a rod, fiber or tube, with two outer dimensions being less than 1 nm and the other outer dimension being greater than 100 nm

c) the particles have a platelet-like shape, where one outer dimension is less than 1 nm and the other outer dimension is greater than 100 nm.

In addition, the national Cosmetics Ordinance must be observed. Anyone who manufactures cosmetic products in Germany must notify the competent authority responsible for monitoring the place of manufacture before placing them on the market. If cosmetic products are imported into the European Union, the person responsible for the import must notify the competent authority responsible for supervision of the place where cosmetic products are brought into the scope of this Regulation (place of import) before they are imported for the first time.


Process flow

The required data is transmitted by you as the responsible person via online forms of the CPNP system of the European Commission and can also be corrected or updated later.

Registration in the CPNP:

In order to be able to use the CPNP, you must complete two primary registration steps:

  • One-time personal registration in EU Login: this provides you with the user name and determines the access password.
  • This is followed by the registration of a company or the application of an existing company via the (SANTE Authorization System, SAAS).

The CPNP can only be used once these registration steps have been carried out and the applications have been completed in accordance with the user profile.

Notification in the CPNP:

You must enter the following data in the CPNP if you are making a cosmetic product available on the European/German market for the first time:

  • the category of the cosmetic product and its name or names by which the specific identification is possible
    • It is not sufficient to merely state the name of a cosmetic series under which various products are marketed.
  • the name and address of the person responsible where the product information file is made easily accessible
  • the country of origin in the case of imports
    • Country of origin does not mean the last country in a supply chain, but rather the country in which the cosmetic product was actually manufactured.
  • the Member State in which the cosmetic product is placed on the market, i.e. made available for the first time
  • the information that makes it possible to contact a natural person if necessary (e.g. first and last name, address, telephone number and e-mail address); information on a legal person alone is not sufficient.
  • the presence of substances in the form of nanomaterials and their identification, including the chemical name
  • the reasonably foreseeable exposure conditions
  • the name and Chemicals Abstracts Service (CAS) or EC number of the substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR)
  • the frame formulation to enable rapid and appropriate medical treatment in the event of difficult incidents

All data you submit to the CPNP will be treated as confidential information and can be corrected and updated at any time.

Requirements
  • Your company produces, has produced or imports cosmetics.
  • You are a "responsible person": Only cosmetic products for which a legal or natural person is named as the "responsible person" on the label within the European Union (EU) or a state of the European Economic Area (EEA) may be placed on the market (usually manufacturer or importer, possibly also distributor).
  • They have access to the CPNP as the "responsible person".
Which documents are required?
  • Information on the responsible person and the cosmetic product, including the name and quantity of the ingredients used
  • label
  • Information on nanomaterials, if applicable
Processing duration

none

Legal basis
Appeal
  • There are no legal remedies against the BVL.
Technically approved by

Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV)

Process flow

The required data is transmitted by you as the responsible person via online forms of the CPNP system of the European Commission and can also be corrected or updated later.

Registration in the CPNP:

In order to be able to use the CPNP, you must complete two primary registration steps:

  • One-time personal registration in EU Login: this provides you with the user name and determines the access password.
  • This is followed by the registration of a company or the application of an existing company via the (SANTE Authorization System, SAAS).

The CPNP can only be used once these registration steps have been carried out and the applications have been completed in accordance with the user profile.

Notification in the CPNP:

You must enter the following data in the CPNP if you are making a cosmetic product available on the European/German market for the first time:

  • the category of the cosmetic product and its name or names by which the specific identification is possible
    • It is not sufficient to merely state the name of a cosmetic series under which various products are marketed.
  • the name and address of the person responsible where the product information file is made easily accessible
  • the country of origin in the case of imports
    • Country of origin does not mean the last country in a supply chain, but rather the country in which the cosmetic product was actually manufactured.
  • the Member State in which the cosmetic product is placed on the market, i.e. made available for the first time
  • the information that makes it possible to contact a natural person if necessary (e.g. first and last name, address, telephone number and e-mail address); information on a legal person alone is not sufficient.
  • the presence of substances in the form of nanomaterials and their identification, including the chemical name
  • the reasonably foreseeable exposure conditions
  • the name and Chemicals Abstracts Service (CAS) or EC number of the substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR)
  • the frame formulation to enable rapid and appropriate medical treatment in the event of difficult incidents

All data you submit to the CPNP will be treated as confidential information and can be corrected and updated at any time.

Requirements

  • Your company produces, has produced or imports cosmetics.
  • You are a "responsible person": Only cosmetic products for which a legal or natural person is named as the "responsible person" on the label within the European Union (EU) or a state of the European Economic Area (EEA) may be placed on the market (usually manufacturer or importer, possibly also distributor).
  • They have access to the CPNP as the "responsible person".

Which documents are required?

  • Information on the responsible person and the cosmetic product, including the name and quantity of the ingredients used
  • label
  • Information on nanomaterials, if applicable

Processing duration

none

Legal basis

Appeal

  • There are no legal remedies against the BVL.

Technically approved by

Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV)

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